FOR USE BY PHYSICIAN ONLY QTY Product Code QTY Product Code Physician Signature: Please reference appropriate product Instructions for Use for a more detailed list of indications, warnings, precautions and potential adverse events and sizing guidelines.
Endurant II - Aortic Stent Grafts | Medtronic
EndurantTM II/IIs AAA Stent Graft System FOR USE BY PHYSICIAN ONLY QTY Product Code Date of CT Study: CT Slice Thickness: Patient ID: Implanting Physician: Evaluation Date: Patient DOB: / / Hospital Name: Procedure Date: SMA patent? Yes No Lowest renal artery Right Left Disease Progression Risk Proximal neck: Short (L1) Wide (D1a) Angled ( A1) Conical (% change D1/L1) Proximal neck thrombus Nil Mild Moderate Severe Proximal neck calcification Nil Mild Moderate Severe Consider EndoAnchors? Yes No Lumbar patent? Yes No IMA patent? Yes No Right iliac calcification Nil Mild Moderate Severe Left iliac calcification Nil Mild Moderate Severe Coil hypo Right No Left Proposed bifur side Right Left QTY Product Code Please reference appropriate product Instructions for Use for a more detailed list of indications, warnings, precautions and potential adverse events and sizing guidelines. Drawing Comments CAUTION: This report is based on information and images provided by the physician to Medtronic. This report is intended to be a resource to support the physician in his/her determination of proper case selection, device sizing, and procedure planning, and is in no way intended to constitute medical advice or in any way replace the independent medical judgment of a trained and licensed physician with respect to any patient needs or circumstances. The physician must conduct his/her own measurements and make his/her own medical judgments based on all of the patient's clinical and diagnostic records and images. The physician is solely responsible for all decisions and any medical judgments relating to patient diagnosis and treatment, including case selection and sizing of the device. Please see the complete Instructions for Use for all product indications, contraindications, precautions, warnings, potential adverse events, and sizing guidelines. Physician Signature: ______________________________________________________________________________________________ EndurantTM II/IIs AAA Stent Graft System PRODUCT CODES ENDURANT II BIFURCATIONS Product Code Proximal Distal Graft Graft Distal Diameter Diameter Design (mm) (mm) Total Covered Delivery Length System (mm) ETBF 23 13 C 124 E ETBF 23 13 C 145 E ETBF 23 13 C 166 E ETBF 23 16 C 124 E ETBF 23 16 C 145 E ETBF 23 16 C 166 E ETBF 25 13 C 124 E ETBF 25 13 C 145 E ETBF 25 13 C 166 E ETBF 25 16 C 124 E ETBF 25 16 C 145 E ETBF 25 16 C 166 E ETBF 28 13 C 124 E ETBF 28 13 C 145 E ETBF 28 13 C 166 E ETBF 28 16 C 124 E ETBF 28 16 C 145 E ETBF 28 16 C 166 E ETBF 28 20 C 124 E ETBF 28 20 C 145 E ETBF 28 20 C 166 E ETBF 32 16 C 124 E ETBF 32 16 C 145 E ETBF 32 16 C 166 E ETBF 32 20 C 124 E ETBF 32 20 C 145 E ETBF 32 20 C 166 E ETBF 36 16 C 145 E ETBF 36 16 C 166 E ETBF 36 20 C 145 E ETBF 36 20 C 166 E ENDURANT IIs BIFURCATIONS Product Code Proximal Distal Graft Graft Distal Diameter Diameter Design (mm) (mm) Total Covered Delivery Length System (mm) ESBF 23 14 C 103 E ESBF 25 14 C 103 E ESBF 28 14 C 103 E ESBF 32 14 C 103 E ESBF 36 14 C 103 E Catheter Outer Diameter (Fr) 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 18 20 20 20 20 20 20 20 20 20 20 Catheter Outer Diameter (Fr) 18 18 18 20 20 LIMBS* Product Code Proximal Distal Graft Graft Distal Diameter Diameter Design (mm) (mm) ETLW 16 10 C Total Covered Delivery Length System (mm) 82 E Catheter Outer Diameter (Fr) Total Contralateral Covered Length with EII/EIIs Bifurcated 14 132 Total Ipsilateral Covered Length with EIIs Bifurcated** 152 ETLW 16 10 C 93 E 14 143 163 ETLW 16 10 C 124 E 14 174 174 194 ETLW 16 10 C 146 E 16 196 196 216 ETLW 16 10 C 156 E 16 206 206 226 ETLW 16 10 C 199 E 16 249 249 269 ETLW 16 13 C 82 E 14 132 152 ETLW 16 13 C 93 E 14 143 163 ETLW 16 13 C 124 E 14 174 174 194 ETLW 16 13 C 146 E 16 196 196 216 ETLW 16 13 C 156 E 16 206 206 226 ETLW 16 13 C 199 E 16 249 249 269 ETLW 16 16 C 82 E 14 132 132 152 ETLW 16 16 C 93 E 14 143 143 163 ETLW 16 16 C 124 E 14 174 174 194 ETLW 16 16 C 146 E 16 196 196 216 ETLW 16 16 C 156 E 16 206 206 226 ETLW 16 16 C 199 E 16 249 249 269 ETLW 16 20 C 82 E 16 132 152 ETLW 16 20 C 93 E 16 143 163 ETLW 16 20 C 124 E 16 174 174 194 ETLW 16 20 C 146 E 16 196 196 216 ETLW 16 20 C 156 E 16 206 206 226 ETLW 16 20 C 199 E 16 249 249 269 ETLW 16 24 C 82 E 16 132 152 ETLW 16 24 C 93 E 16 143 163 ETLW 16 24 C 124 E 16 174 174 194 ETLW 16 24 C 146 E 16 196 196 216 ETLW 16 24 C 156 E 16 206 206 226 ETLW 16 24 C 199 E 16 249 249 269 ETLW 16 28 C 82 E 16 132 152 ETLW 16 28 C 93 E 16 143 163 ETLW 16 28 C 124 E 16 174 174 194 ETLW 16 28 C 146 E 16 196 196 216 ETLW 16 28 C 156 E 16 206 206 226 ETLW 16 28 C 199 E 16 249 249 269 *The limb mates with the AUI stent graft on the ipsilateral side. These calculations assume the minimum 30 mm overlap between the bifurcated stent graft and the contralateral iliac limb per the Endurant II Stent Graft System Instructions for Use. When using the 124 mm length bifurcated stent graft, subtract 10 mm from Total Contralateral Covered Length with Bifurcated. **The 3-5 stent overlap is available only with select limbs. Please refer to the Instructions for Use for more information. AORTIC EXTENSIONS Product Code Proximal Distal Graft Graft Distal Diameter Diameter Design (mm) (mm) ETCF 23 23 C ETCF 25 25 C ETCF 28 28 C ETCF 32 32 C ETCF 36 36 C ETTF 23 23 C ETTF 25 25 C ETTF 28 28 C ETTF 32 32 C ETTF 36 36 C ILIAC EXTENSIONS Product Code Proximal Distal Graft Graft Distal Diameter Diameter Design (mm) (mm) ETEW 10 10 C ETEW 13 13 C ETEW 20 20 C ETEW 24 24 C ETEW 28 28 C AUI Product Code Proximal Distal Graft Graft Distal Diameter Diameter Design (mm) (mm) ETUF 23 14 C ETUF 25 14 C ETUF 28 14 C ETUF 32 14 C ETUF 36 14 C Total Covered Delivery Length System (mm) 49 E 49 E 49 E 49 E 49 E 70 E 70 E 70 E 70 E 70 E Total Covered Delivery Length System (mm) 82 E 82 E 82 E 82 E 82 E Total Covered Delivery Length System (mm) 102 E 102 E 102 E 102 E 102 E UC201607031c EN ©2020 Medtronic. All rights reserved. Medtronic and the Medtronic logo are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. For distribution in the USA only. 12/2020 Catheter Outer Diameter (Fr) 18 18 18 20 20 18 18 18 20 20 Catheter Outer Diameter (Fr) 14 14 16 16 18 Catheter Outer Diameter (Fr) 18 18 18 20 20 Indications The EndurantTM II/EndurantTM IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FXTM EndoAnchorTM system when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short ( 4 mm and < 10 mm) infrarenal necks (see Neck length definition below). The Endurant II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs stent graft system is indicated for use in patients with the following characteristics: Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories Proximal neck length of 10 mm; or 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor system (bifurcated stent graft only) Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter. Infrarenal neck angulation of 60° Aortic neck diameters with a range of 19 to 32 mm Distal fixation length(s) of 15 mm Iliac diameters with a range of 8 to 25 mm Morphology suitable for aneurysm repair Contraindications The Endurant II/Endurant IIs stent graft system is contraindicated in: patients who have a condition that threatens to infect the graft patients with known sensitivities or allergies to the device materials When used with the Heli-FX EndoAnchor system, the Endurant II/IIs stent graft system is also contraindicated in: patients with known sensitivities to the EndoAnchor implant materials. For contraindications regarding ancillary devices used with the Endurant II/Endurant IIs stent graft system, refer to the Instructions for Use provided with the device. Warnings and Precautions The long-term safety and effectiveness of the Endurant II/ Endurant IIs stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft), or less than the recommended number of EndoAnchor implants when used in short proximal necks ( 4 mm and < 10 mm), should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. The Endurant II/Endurant IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin. Studies indicate that the danger of micro-embolization increases with increased procedure duration. The safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details. MRI Safety and Compatibility Non-clinical testing has demonstrated that the Endurant II/Endurant IIs stent graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional MRI safety information, please refer to the product Instructions for Use. Adverse Events Potential adverse events include (arranged in alphabetical order): amputation; anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement; aneurysm rupture and death; aortic damage, including perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/ or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma or coagulopathy; bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb); death; edema; EndoAnchor system (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage); embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence; infection of the aneurysm, device access site, including abscess formation, transient fever and pain; lymphatic complications and subsequent attendant problems (e.g., lymph fistula); neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); occlusion of device or native vessel; pulmonary complications and subsequent attendant problems; renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; surgical conversion to open repair; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); vessel damage; wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis) Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. medtronic.com/aortic UC201607031c EN ©2020 Medtronic. All rights reserved. Medtronic and the Medtronic logo are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. For distribution in the USA only. 12/2020Adobe PDF Library 15.0 Adobe InDesign 14.0 (Macintosh)